A recent poll shows a strong desire among patients to play a more active role in medical research. The poll, fielded shortly before the launch of a new book highlighting the phenomenon of patient-led research, sends a clear message to pharma: embrace the patient’s role in identifying new molecules.

“Companies like Genentech, Merck, Janssen and Roche are asking these kinds of questions, about how much are we involving that end customer in the process, and would there be benefit to doing so more frequently and in a more significant way,” said Fabio Gratton, chief business officer for Vocalize, whose Truvio mobile research platform was used to find out what health activists think about the patient-led research trend.

The act of patients reporting their own medical results, or using networks and data to actively recruit researchers from the private and public sectors to accelerate clinical trials, is just one of 15 trends digital-health trends discussed in the recent book, “ePatient 2015: 15 Surprising Trends Changing Health Care,” which launched last week.

The book details ways mobile technology, genomics, sensors and other new health tools are poised to benefit patients, caregivers and physicians. The 15 trends align around three big themes: health hyper-efficiency, the personalized health movement and digital peer-to-peer healthcare.

It’s under this last heading that co-authors Rohit Bhargava and Fard Johnmar classify “accelerated trial-sourcing.” The idea of patient-centered trial sourcing is nothing new. The trend, authors say, has roots in the AIDS protests of the 1980s and 1990s. 

“Accelerated Trial-Sourcing (like the AIDS movement before it) is all about patients fighting against the notion they have no say in medical research and that slow elegant science is the optimal way to bring new therapies to market,” Johnmar told MM&M by email.

“The difference between then and now,” he added, “comes down to how rapidly these efforts can be coordinated globally and the results can be shared immediately, thanks to the range of digital technologies and social networking tools that were largely unavailable decades ago.” 

To get an idea of what today’s influential patients think, members of the Wego Health online community were asked to share their opinions on accelerated trial-sourcing. Participants were asked, “Do you believe that patients, and those who care for them, should play an active role in how medical research is conducted by pharmaceutical companies, academic institutions, and other organizations?”

Within 24 hours of deployment on the voice-response research platform, quantitative and qualitative responses were received from 50 “health activists” (consumer KOLs who run online communities and have scores of followers), 88% of whom said yes, patients should play a more active role in medical research, 2% no, and 10% unsure. 

Among the “yes” votes, one commenter said, “If something is ailing me, I want to be as important as the doctor—trying to make sure I understand what is going on with me and doing what I can to do things [about it]. Because I know my body better than my doctor.”

The patients were also asked whether pharma should actively collaborate within research, and again they responded overwhelmingly (94%) in the affirmative. “Patients and their caregivers are the ones that actually understand the disease process the best, because it’s happening to us,” said one in this group. 

Just how do patients and caregivers foresee playing a greater role? Among recommendations made by the respondents were these six, as highlighted by Truvio:

1.   Patient-friendly trial results: A “patient friendly” version of the clinical trial results (similar to the updated patient-friendly PI format) that makes clinical trials more “accessible,” thereby increasing participation

2.   Trial trendspotters: A disease-specific panel of influencers that acts before and during trials to add more details to specific disease trends that arise as data are gathered

3.   Crowdsourced trial design: Ensures trial design aligns with the community’s abilities and desires (some pharma companies are already using this technique)

4.   Recruitment dashboard: Provides study volunteers with real-time feedback on where they are in the process

5.   “Unmet need” tracker: Tracks the need for trials within underserved disease states

6.   Live trial “Q&A” board: A private social community for current trial participants where they can ask questions to sponsors, investigators and other patients anonymously and in a way that protects the trial’s integrity

Gratton, who referred to Wego Health activists as “the electoral college of all e-patients,” said their sentiments, based on the trends outlined in the ePatient 2015 book, could serve as a “directional arrow” for industry. 

It’s no surprise that today’s patients reflect this view, added Johnmar. “Today’s Health Activists are not alone in their belief that pharma companies should recognize, support and collaborate with patients seeking to guide or initiate clinical research,” he noted. “During the height of the AIDS crisis, patient advocates staged protests, met with pharma companies and engaged in other activities designed to accelerate AIDS research and bring safe, effective treatments to market. Today, the issues faced by AIDS advocates have not gone away.”

Today’s analog is amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, he and Bhargava write in the book. There is no cure for ALS and current treatments are, at best, only partially effective. This is why a group of ALS patients used the internet, social networks and data analysis tools to conduct their own test of a home-brewed experimental drug.

Self-reported data suggested the chemical was benefiting some patients. But after examining data on the effectiveness of the drug, PatientsLikeMe—the online research platform—concluded that the agent, sodium chlorite, was ineffective and may even worsen some patients’ ALS, according to one example in the book.

This anecdote, one of many from the book, also serves as a cautionary tale for what can happen when patients are driven to act on their own. Amidst the fundamental shift in how patient empowerment is driving more speed in medical research, some are wary of taking too much of a “real-time” patient-driven approach to medical research, either because of the unproven safety of drugs taken electively prior to controlled clinical trials, unreliability of the results, or even the harm DIY studies could do by surfacing side effects that could dissuade people from entering bona-fide clinical trials.

The authors predict that these concerns will not prevent the accelerated trial-sourcing movement from progressing.

“For some patients (and their families)—especially those with rare conditions—the pace of medical research is much too slow and uninformed by their real-world experiences with medications and the health system,” Johnmar told MM&M.  “Executives at pharmaceutical companies are rightly concerned about the legal, regulatory and safety issues associated with patient-led or informed research, but they can only benefit by bringing patients more deeply into the research process.”